Centralized Monitoring Associate/CM
IQVIA Holdings Inc.
Kochi, India
1d ago

Job Overview

Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices.

To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts.

To ensure the work is conducted as per SOPs, Policies and Good clinical practice’s and applicable regulatory requirements.

Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.

Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.

Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOPs, International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance.

Develop and use of study management plans and / or risk-based monitoring specific tools and templates and / or other study specific plans to evaluate the quality and integrity of the study.

Support project management team to develop monitoring strategy including monitoring triggers / thresholds. Manage the operational insight of the assigned project(s) and complete the study / site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)

Qualifications

  • Bachelor's Degree Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification.
  • Requires minimum of 2 years of relevant work experience or equivalent combination of education, training and experience.
  • Fresher with Medical or Allied medical degree.
  • Experience in clinical research field preferred.
  • Experience level may vary based on customer specific requirements.
  • Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.
  • i.e. International Conference on Harmonisation - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
  • Good Clinical system expertise.
  • Strong written and verbal communication skills including good command of English language.
  • Results and detail-oriented approach to work delivery and output.
  • Understanding of clinical / medical data.
  • Good motivational, influencing, coaching skills.
  • Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
  • Strong organizational and problem-solving skills.
  • Effective presentation skills.
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
  • Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.
  • At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.

    The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our ,+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

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